This trial is active, not recruiting.

Conditions colorectal neoplasms, melanoma, prostatic neoplasms, renal cell carcinoma, neoplasms, patients who have/have had melanoma and other tumors
Treatment cp-675,206 (tremelimumab)
Phase phase 2
Sponsor AstraZeneca
Start date March 2008
End date December 2016
Trial size 38 participants
Trial identifier NCT00378482, A3671024, D4881C00024


This study is intended to provide access to CP-675,206 for patients who have previously received CP-675,206 in a clinical trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Drug: CP-675,206 (Tremelimumab)
cp-675,206 (tremelimumab) anti-CTLA4 human monoclonal antibody
15 mg/kg IV every 3 months as long as required

Primary Outcomes

Safety Endpoints: • Serious adverse events • Grade 3 or 4 CP-675,206-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to CP-675,206
time frame: as long as required
Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival
time frame: as long as required

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - The subject must have already received CP-675,206 in another protocol - Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator. - Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures Exclusion Criteria:

Additional Information

Official title A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.
Location data was received from the National Cancer Institute and was last updated in July 2016.